Adding romosozumab to estrogen therapy for low bone mass in young women with lost periods
Romosozumab as an adjunct to physiologic estrogen replacement in adolescents and young adults with functional hypothalamic amenorrhea
Monthly romosozumab injections combined with estrogen patches aim to help build bone in adolescents and young adult women with functional hypothalamic amenorrhea.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Massachusetts General Hospital NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11317011 on NIH RePORTER |
What this research studies
You would be randomly assigned (more likely to get the active drug than placebo) in a double-blind trial that lasts about 12 months. For the first 6 months you would get monthly injections of romosozumab or matching placebo while wearing a transdermal estradiol patch and taking calcium and vitamin D; at month 6 everyone receives a single intravenous dose of zoledronic acid to help consolidate gains. The study measures bone mineral density, bone structure scans, and blood markers to see how your bones respond. About 84 participants will be enrolled and the team will use DXA, high-resolution peripheral CT, and computer-based strength modeling to track changes.
Who could benefit from this research
Good fit: Adolescent and young adult females with functional hypothalamic amenorrhea (for example from anorexia nervosa or exercise-related amenorrhea) who have low bone mass and are candidates for estrogen replacement are the intended participants.
Not a fit: People who have normal menstrual function, older adults who have already reached peak bone mass, those who cannot take estrogen or romosozumab, or those who are pregnant or breastfeeding would not be expected to benefit from this trial.
Why it matters
Potential benefit: If successful, the approach could increase bone mass and improve bone strength in young women with FHA, potentially reducing future fracture risk.
How similar studies have performed: Romosozumab has reliably increased bone density and reduced fractures in postmenopausal osteoporosis, but using it to boost bone accrual in adolescents and young adults with FHA is a new and relatively untested approach.
Where this research is happening
Boston, United States
- Massachusetts General Hospital — Boston, United States (Active)
Researchers
- Principal investigator: Miller, Karen K — Massachusetts General Hospital
- Study coordinator: Miller, Karen K
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.